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Antiseptics and Disinfectants for the Treatment Of Verstraelen et al. BMC Infectious Diseases 2012, 12:148 http://www.biomedcentral.com/1471-2334/12/148 RESEARCH ARTICLE Open Access Antiseptics and disinfectants for the treatment of bacterial vaginosis: A systematic review Hans Verstraelen1*, Rita Verhelst2, Kristien Roelens1 and Marleen Temmerman1,2 Abstract Background: The study objective was to assess the available data on efficacy and tolerability of antiseptics and disinfectants in treating bacterial vaginosis (BV). Methods: A systematic search was conducted by consulting PubMed (1966-2010), CINAHL (1982-2010), IPA (1970- 2010), and the Cochrane CENTRAL databases. Clinical trials were searched for by the generic names of all antiseptics and disinfectants listed in the Anatomical Therapeutic Chemical (ATC) Classification System under the code D08A. Clinical trials were considered eligible if the efficacy of antiseptics and disinfectants in the treatment of BV was assessed in comparison to placebo or standard antibiotic treatment with metronidazole or clindamycin and if diagnosis of BV relied on standard criteria such as Amsel’s and Nugent’s criteria. Results: A total of 262 articles were found, of which 15 reports on clinical trials were assessed. Of these, four randomised controlled trials (RCTs) were withheld from analysis. Reasons for exclusion were primarily the lack of standard criteria to diagnose BV or to assess cure, and control treatment not involving placebo or standard antibiotic treatment. Risk of bias for the included studies was assessed with the Cochrane Collaboration’s tool for assessing risk of bias. Three studies showed non-inferiority of chlorhexidine and polyhexamethylene biguanide compared to metronidazole or clindamycin. One RCT found that a single vaginal douche with hydrogen peroxide was slightly, though significantly less effective than a single oral dose of metronidazole. Conclusion: The use of antiseptics and disinfectants for the treatment of BV has been poorly studied and most studies are somehow methodologically flawed. There is insufficient evidence at present to advocate the use of these agents, although some studies suggest that some antiseptics may have equal efficacy compared to clindamycin or metronidazole. Further study is warranted with special regard to the long-term efficacy and safety of antiseptics and disinfectants for vaginal use. Keywords: Bacterial vaginosis, Antiseptics, Disinfectants, Therapy, Systematic review, Chlorhexidine, Polyhexamethylene biguanide, Hydrogen peroxide Background association with ascending genital tract infection and Bacterial vaginosis (BV) is a condition characterised by with sexually transmitted infections [2]. the partial loss of the indigenous vaginal lactobacilli Current recommendations by the Centres for Disease coupled with polymicrobial anaerobic overgrowth of the Control and Prevention (CDC) for the treatment of BV vaginal epithelium. Although BV often remains asymp- basically involve antibiotic treatment with oral or intra- tomatic, it is one of the most common causes of vagin- vaginal metronidazole or clindamycin [3]. Although itis, and hence among the most common reasons for these treatment modes are associated with fairly good women to seek medical help [1] In recent years BV has short-term cure rates, they fail to prevent BV in at least further emerged as a global issue of concern due to its half of the cases in the long run [4]. Several alternative treatment approaches are therefore being (re)considered, including the use of antiseptics and disinfectants. * Correspondence: [email protected] 1Department of Obstetrics & Gynaecology, Faculty of Medicine and Health Antiseptics have been used for over half a century in the Sciences, Ghent University, De Pintelaan 185, B-9000, Ghent, Belgium treatment of vaginal infections. Similar to antibiotics, Full list of author information is available at the end of the article © 2012 Verstraelen et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Verstraelen et al. BMC Infectious Diseases 2012, 12:148 Page 2 of 8 http://www.biomedcentral.com/1471-2334/12/148 antiseptics facilitate the eradication of the anaerobic vagi- mercuric amidochloride, phenylmercuric borate, mercuric nal microbiota associated with bacterial vaginosis which chloride, mercurochrome, mercury, thiomersal, mercuric allows for the recolonisation of indigenous lactobacilli. iodide, phenylmercuric borate, silver nitrate, silver, hydro- Antiseptics generally have a very broad spectrum as they gen peroxide, eosin, propanol, tosylchloramide sodium, act non-specifically on bacteria through mechanisms such isopropanol, potassium permanganate, sodium hypochlor- as bacterial cell membrane disruption. In accordance, ite, and ethanol. there are very few reports on antimicrobial resistance to In addition we accounted for benzydamine which is these agents. Nonetheless, antiseptics and disinfectants listed under ATC code G02CC03 for “anti-inflammatory have become unpopular for the purpose of treating vaginal products for vaginal administration”, considering benzy- infections, presumably because they are often used as damine also has broad antimicrobial activity. over-the-counter (OTC) products associated with vaginal Only English-language studies were considered for re- douching, a common practice that has been associated view. Additional studies were searched for by checking with the occurrence of BV. In many countries, antiseptics cross-references cited in the primary studies. No efforts are still marketed for the treatment of vaginal infections, were made to identify unpublished studies. though their efficacy has not been supported by a sound evidence base. We therefore sought to assess currently Types of studies available data on the efficacy and tolerability of antiseptics Reports were considered eligible if they involved clinical and disinfectants in the treatment of BV. Through a sys- trials in which the efficacy and tolerability of antiseptics tematic literature search, we identified and evaluated clin- and disinfectants in the treatment of BV was assessed in ical trials that compared antiseptic and/or disinfectant comparison to placebo or in comparison to standard treatment to either placebo or standard antibiotic treat- antibiotic treatment with metronidazole or clindamycin. ment in women of any age. Studies were considered eligible if at least 40 study participants had been enrolled for comparison between Methods the two treatment arms. Objectives The overall objective is to summarize currently available data (published up to December 31 2010) on the efficacy Types of participants and tolerability of antiseptics and disinfectants in the treat- Women of any age diagnosed with bacterial vaginosis ment of BV, thereby accounting for the quality of the clin- through standardized criteria like Amsel’s or Nugent ical trials identified through a systematic literature search. criteria [5,6]. No study was excluded because of (pos- sible) co-infection with sexually transmitted infections. Search strategy An electronic search was conducted by consulting the Types of intervention following databases: PubMed (1966-2010), CINAHL We confined our review to antiseptics and disinfectants for (1982-2010), International Pharmaceutical Abstracts which the dosage and treatment regimen was specified, and (IPA) database (1970-2010), and the Cochrane Central which are listed in the Anatomical Therapeutic Chemical Register of Controlled Trials. (ATC) Classification System under the code D08A (“anti- Clinical trials were searched for by use of the key words septics and disinfectants”). In addition we accounted for “bacterial vaginosis” and “non-specific vaginitis” in com- benzydamine which is listed under ATC code G02CC03 for bination with “disinfectant”, “antiseptic”, and subse- “anti-inflammatory products for vaginal administration”, quently with all generic names of antiseptics and considering benzydamine also has broad antimicrobial ac- disinfectants listed in the Anatomical Therapeutic Chem- tivity. Hence, we excluded any report in which any antisep- ical (ATC) Classification System under the code D08A tic product (e.g. herbal medicines) was used for which the (Antiseptics and disinfectants), i.e. ethacridine lactate, chemical composition and/or substance dose was not verifi- aminoacridine, euflavine, aluminium agents, dibrompro- able. Treatment with an antiseptic or disinfectant was con- pamidine, chlorhexidine, propamidine, hexamidine, poly- sidered in any preparation type, any dosage regimen, and hexanide, boric acid, hexachlorophene, policresulen, any route of administration. phenol, triclosan, chloroxylenol, biphenylol, nitrofural, iodine/octylphenoxypolyglycolether, povidone-iodine, iod- ine, diiodohydroxypropane, dequalinium, chlorquinaldol, Types of outcome measures oxyquinoline, clioquinol, benzalkonium, cetrimonium, The primary outcome was cure of bacterial vaginosis as cetylpyridinium, cetrimide, benzoxonium chloride, dide- assessed through use of the Amsel criteria or Nugent cyldimethylammonium chloride, benzethonium chloride, criteria at least 7 days following treatment initiation. octenidine, benzethonium chloride, dodeclonium bromide, Cure was defined as a Nugent score <7 or the presence Verstraelen et al. BMC Infectious Diseases
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